Home NDC 41520-034 Nighttime Sleep Aid
Product NDC 41520-034
11-digit product format 415200034
Labeler code 41520
Product ID 41520-034_dc496e69-0bf8-4215-ac37-4f7256115d90
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form LIQUID
Route ORAL
Labeler Care One (American Sales Company)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-06-30
Marketing end 2026-10-30
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 mg/30mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Nighttime Sleep Aid Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1248354 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41520-034-06 Nighttime Sleep Aid 177 mL in 1 BOTTLE, PLASTIC LIQUID 177 7 41520-034-12 Nighttime Sleep Aid 355 mL in 1 BOTTLE, PLASTIC LIQUID 355 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-034 NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) LIQUID [CARE ONE (AMERICAN SALES COMPANY)] 6 Current NDC, Legacy NDC, 2 package rows 20240306_bd5de3b3-7cb5-4403-b664-23ac70b9957f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41520-034-06 41520003406 177 mL in 1 BOTTLE, PLASTIC (41520-034-06) 177 ml 2015-06-30 2026-10-30 No No Current 41520-034-12 41520003412 355 mL in 1 BOTTLE, PLASTIC (41520-034-12) 355 ml 2015-06-30 2026-10-30 No No Current